Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HMPL-506 · 1 trial · 1 indication
Incidence of serious Dose-limiting Toxicity evaluated using the NCI CTCAE V5.0.
Incidence of serious adverse events (SAEs) evaluated using the NCI CTCAE V5.0 and the relationship of DLTs and SAEs with the investigational product. The assessment window is from the first dose of HMPL-506 to 30 days after last dose, or initiation of a new anti-tumor therapy, whichever comes first.
Performing anti-tumor efficacy evaluation of HMPL-506 based on Complete response (CR), Complete response with partial recovery of hematology (CRh), Complete response with incomplete hematological recovery (CRi) assessed by the Investigator. Response evaluation in AML will be conducted based on the European LeukmiaNet (ELN) 2022 criteria; response evaluation in ALL will be conducted based on the National Comprehensive Cancer Network (NCCN) Guidelines for the Diagnosis and Treatment of ALL (2023 Version 3).
| Arm | Type | Description |
|---|---|---|
| 50mg QD | EXPERIMENTAL | The starting dose of 50 mg QD will be escalated using the accelerated titration design in the first enrolled subject. If no DLT is observed and no Grade 2 or higher investigational product-related adverse events occur during the DLT observation period at the dose 50mg QD, the dose can be escalated to 100 mg QD, and the mTPI-2 design will be used for dose escalation. The dose will be escalated based on available efficacy and safety data in conjunction with preclinical Pharmacodynamics, Pharmacokinetic (PK) and Pharmacodynamics (PD) data. |
| 100mg QD | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| 200mg QD | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| 300mg QD | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| 400mg QD | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| 25 mg BID | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| 50mg BID | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| 75 mg BID | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| 150mg QD | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| 100mg BID | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| 150mg BID | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| 200mg BID | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| Other dose determined by SRC | EXPERIMENTAL | At least 3 patients will be enrolled at each dose level and additional 3 patients will be recruited at the dose level decided by the next cohort following the rules specified in the protocol when all patients in the current dose group complete the DLT assessment. The number of patients finally enrolled in each dose group is not limited to 3 patients, and the need to increase the number of patients may be decided by the sponsor or by discussion at a SRC meeting to obtain the relevant data required. However, at least 3 DLT evaluable patients per dose group must be ensured. |
| Name | Type | Description |
|---|---|---|
| HMPL-506 | DRUG | HMPL-506 will be administered orally in 28-day cycles, until disease progression/relapse , death, intolerable toxicity, receipt of another anti-tumor therapy (including HSCT), failure to further benefit , patient withdrawal, loss to follow-up or end of the study, whichever comes first. |
Inclusion Criteria: * Subjects must meet all of the following criteria to be eligible for enrolment. 1. Having understood this study adequately and being voluntary to sign the ICF; 2. Age ≥18 years; 3. 1\) Dose escalation phase: patient with MLL-rearranged and/or NPM1-mutant relapsed/refract...
HMPL-506 is an investigational small molecule being developed for the treatment of hematological malignancies, which are cancers of the blood and bone marrow. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
HMPL-506 targets menin, a protein involved in gene regulation. By inhibiting menin, the drug aims to interfere with pathways that drive the growth of hematological malignancies. This mechanism is being studied in a Phase 1 clinical trial.
HMPL-506 is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting clinical research on this drug for hematological malignancies.
HMPL-506 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with hematological malignancies.
HMPL-506 is being studied in a Phase 1 clinical trial with the identifier NCT06387082, titled "A Clinical Study of HMPL-506 in Patients With Hematological Malignancies." The trial is recruiting participants in China and aims to enroll 132 patients aged 18 years and older.